2/26/2026

speaker
Operator
Conference Call Operator

Good day and thank you for standing by. Welcome to the NovaCure fourth quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I'd now like to hand the conference over to Adam Dainey, Head of Investor Relations. Please go ahead.

speaker
Adam Dainey
Head of Investor Relations

Good morning, and thank you for joining us to review Novacure's fourth quarter and full year 2025 performance. I'm joined on the phone today with our Executive Chairman Bill Doyle, CEO Frank Leonard, and CFO Christophe Brockman. Other members of our executive leadership team will be available for Q&A. For your reference, Slides accompanying this earnings release can be found on our website at www.novacure.com on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions today during this conference call will include forward-looking statements, and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties, some of which are beyond our control and are described from time to time in our SEC filings. We do not intend to update publicly any forward-looking statement except as required by law. Where appropriate, we will refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation. We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items, and best reflects the financial value generated by our business. We do not provide forward-looking guidance for adjusted EBITDA on a GAAP basis due to the inability to predict share-based compensation expenses contained in the reconciled GAAP measure net income without reasonable efforts. Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earnings slides, and in our Form 10-K filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website. Following our prepared remarks this morning, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle. Thank you, Adam.

speaker
Bill Doyle
Executive Chairman

I'll begin this morning with a brief review of our 2025 accomplishments and look ahead to 2026. Our CEO, Frank Leonard, will then discuss recent commercial updates. And finally, our CFO, Christoph Brackman, will walk through our fourth quarter financial performance and 2026 guidance before opening the line for questions. 2025 was a year of progress and change at Novacure. We generated a record $655 million in net revenues last year, an 8% increase from 2024. We presented final data from two large randomized trials and plenary sessions at major medical congresses, followed by publications in leading medical journals. We submitted PMA applications to the FDA for the use of TT Fields therapy to treat pancreatic cancer and brain metastases from non-small cell lung cancer. And we rolled out product enhancements designed to improve the TT Fields therapy experience for both patients and physicians. 2025 was a strong year of execution, setting the stage for a catalyst-rich 2026. We expect to reach a number of regulatory, clinical, and commercial milestones this year. The first milestone was reached earlier this month with the approval of Optune PACS for the treatment of locally advanced pancreatic cancer. And we have submitted regulatory filings for Optune PACS in Europe and Japan. We expect Optune PACS to be a significant contributor to our long-term growth and are eager to begin treating patients in the coming weeks. We also expect a decision from the FDA on our brain metastases PMA later this year. On the clinical front, we are on track for top line readouts from both the Panova 4 and Trident trials this year. Panova 4 is a phase two trial exploring the use of TT fields, atezolizumab, a checkpoint inhibitor, and chemotherapy in metastatic pancreatic cancer, with top-line data anticipated next month. Trident is a Phase III trial exploring earlier use of TT fields concomitant with radiation and temozolomide in newly diagnosed GBM, which we expect to read out in Q2. We are also on track to complete enrollment of our next Phase III trial, Keynote D58, studying tumor-treating fields, hemazolamide, and the checkpoint inhibitor pembrolizumab in newly diagnosed GBM by year end. Turning to our commercial portfolio, we anticipate a number of national or regional launches of our three products this year. This includes OptumGEO launches in Spain, Czechia, and the Canadian province of British Columbia, an OptumLua launch in Japan, and Optune PAC launches in the U.S. and Germany. Before I hand the call over to Frank, I would like to touch on one update from this morning's press release. Dr. Nicholas Le Pen, our chief medical officer, resigned from the company effective February 25. Following Nicholas's departure, we have decided to combine our scientific and clinical organizations to accelerate our R&D execution and shorten the cycle from scientific insight to clinical relevance. Dr. Uri Weinberg, our Chief Innovation Officer, will now also assume the role of Chief Medical Officer. Dr. Weinberg joined NovaCure in 2008 and has been instrumental in establishing and leading a number of our scientific and research and development functions over the years. Uri is well qualified to take over this dual mandate. I would like to personally thank Nicholas for his contributions to Novacure and to congratulate Uri on his expanded role. With that, let me hand the call to Frank to walk through recent updates.

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